Urinary dysfunction is one of those medical conditions that can be life-altering, especially because of the deep stigma associated with it. Current solutions are cumbersome and can be embarrassing.
One promising technology, the neuromodulation device, can be used to stimulate nerves and keep a patient's urethra closed. But these implanted devices—which have helped people with everything from depression and Parkinson's to Alzheimer's and epilepsy—have bulky remotes and require frequent charging; patients have to sit plugged into a wall for two to four hours.
Enter Axonics, a company that has partnered with design firm Karten Design to rethink how a sacral neuromodulation (SNM) device can improve the lives of people who suffer from incontinence. Their solution? A mobile charger and a low-profile remote control that looks like a key fob.
Stuart Karten, principal at Karten Design, worked with a team of behavioral and cognitive scientists to understand how the incontinence affects patients' day-to-day existence and emotional well-being. "We heard from a number of people that they just wouldn't leave the house and were so in fear of wetting themselves or not being able to find a bathroom," Karten says. "They collapsed their world to just their house."
Sacral neuromodulation works by stimulating the sacral nerve, which controls the opening to the urethra. Patients can adjust the strength of the pulse, turning it up and down as need be throughout their day, if they feel an urge coming on or if they're being particularly active. The technology works best when patients can find a balance between the body's natural mode and the implanted technology, which provides assistance to prevent leakage.
Karten wasn't focused on the implanted device, but the user experience of the surrounding devices—the remote control that increases and decreases the intensity of the neuromodulation, and the charger.
Early prototypes of the Axonics SNM featured a remote control with a screen user interface that looked like a cell phone—but Karten said that the patients almost universally rejected it. Not only did they not want to lug around another phone-shaped device, but pulling out a bigger controller when you're in a meeting or out with friends leads to questions, which can often make the person feel shame. (Currently the FDA doesn't allow iPhone or Android-controlled implants, so an app was out of the question.)
Instead, Karten designed a small, fob-shaped remote with no screen that could easily stay on a keychain or in a pocket. With only a few raised buttons that increase and decrease the strength of the pulse and reveal how much battery is left, the remote is inconspicuous and easy to use subtly. The remote also offers a sense of control over a foreign object within the body, leading to greater engagement.
One of the biggest design challenges Karten faced with the Axonics SNM was how to create a mobile charging solution so that patients could actively move about their home while recharging. To charge, patients slowly hover the round charger over their skin in the area where the implant is located. A tone helps them locate exactly where the implant is—kind of like a metal detector finding coins buried in the sand. Once the patient has located the right spot, which is the only effective way to charge, they flip the adhesive wings over the body of the charger and press down, and the charger binds to the skin. There's also the option to use a belt, especially right after surgery. It works the same way without using the adhesive.
The Axonics SNM system is currently approved for sale in the EU, and the company hopes to have FDA clearance in the United States in 2018.
"It’s life changing for most people that they can go about their normal habits for the day without having to be concerned about where the bathroom is," Karten says.